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Table 2 Preventive and chronic disease management services included in the cluster-randomized clinical trial

From: Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial

Preventive service

Target

Cancer screenings

 1

Breast cancera

Every 2 years

 2

Cervical cancer

Co-testing (hrHPV testing plus cytology) every 5 years

 3

Colorectal cancer

Decennial colonoscopyb

 4

Lung cancer

Every 1 year

Cardiovascular disease reduction

 5

Abdominal aortic aneurysm screening

Once

 6

Blood pressure controlc

130/80 mmHg

 7

Lipids controlc

30% (low-intensity statins) or 50% (moderate-high intensity statins) reduction in LDLd

Diabetes control

 8

Diabetes controlc

If baseline 7.0–7.9%, 8.0–8.9%, 9.0–10.9%, ≥11.0%: HbA1c = 1 point reduction, 7%, 2 point reduction, 9%, respectively

Healthy lifestylee

 9

Alcohol misusec

≤1 drink/day (female) or ≤2 drinks/day (male)

 10

Bariatric surgeryc,f

Mean of roux-en-Y gastric bypass and sleeve gastrectomy

 11

Healthy diet

Lowest quintile of risk based on NHANES cycles 2013–2014 through 2017–2018

 12

Light exercise

30 min per day

 13

Moderate-vigorous exercise

150 min moderate or 75 min vigorous exercise per week, plus muscle strengthening exercise 2 days per week

 14

Tobacco cessationc

Quit smoking

Vaccines

 15

Influenza vaccineg

Annual

 16

Pneumonia vaccineg

PPSV23 (1–2 doses based on ACIP guidelines)

 17

Tetanus vaccineg

Decennial

 18

Zoster vaccineg

Two doses of Shingrix

Other

 19

Hepatitis C virus (HCV) testingg

Once

 20

HIV testingg

Once (low-risk individuals) or annual (high-risk individuals)

 21

Osteoporosis screening/falls preventiong

Once

 22

Testing for sexually transmitted infectionsg

Annual in high-risk individuals

  1. For each preventive service, the model defines eligibility based on the most recent USPSTF recommendation
  2. ACIP Advisory Committee on Immunization Practices, BMI body mass index, hrHPV high-risk human papilloma virus, RCT randomized clinical trial, USPSTF United States Preventive Services Task Force
  3. aThe RCT excludes BRCA1/BRCA2 genetic testing and breast cancer chemoprevention, which are more relevant in younger women [22, 23] and often require specialist genetic counseling
  4. bAnnual fecal immunochemical testing is assumed to provide 90% of decennial colonoscopy benefit, based on a decision analysis accompanying the 2016 USPSTF recommendation [24]
  5. cThe RCT defines a target of risk factor control, rather than a USPSTF recommendation for screening or counseling. Diabetic foot exam is not included because it is expected to be routinely conducted at the baseline primary care visit for eligible patients, without need for shared decision-making. Diabetic eye exam is not included because many eligible Cleveland Clinic Health System patients obtain these exams from providers outside of the health system (e.g., opthamologist in private practice)
  6. dStatin dosage will be assumed based on American College of Cardiology recommendations
  7. eDepression screening not included because, typically, it would be faster to screen than to have a discussion about whether the screen a patient. Depression control not included because it is symptomatic; the focus of this RCT is primary prevention and asymptomatic chronic condition (or risk factor) control
  8. fThe USPSTF recommends weight loss counseling, which this RCT considers achievable through ≥1 of the following: bariatric surgery (assumed eligibility criteria: BMI≥40 kg/m2 or ≥35 kg/m2 in individuals with diabetes), healthy diet, and/or exercise. As with all services considered by the RCT, the individualized recommendations do not make a recommendation for or against receipt of bariatric surgery. The study assumes that a patient interested in bariatric surgery would have a discussion with his/her primary care provider and then a specialist. Additionally, the study team notes evolving evidence on medication (semaglutide) for weight loss, which may eventually be added to the RCT at the team’s discretion. The study team also may add a service Lose 10 lbs., intended to roughly proxy 5% weight loss, based on expected weight loss across available interventions (e.g., light exercise, partial adherence to healthy diet)
  9. gBecause the net benefit is likely to be small at the individual level (roughly, the public health benefit divided by the size of the at-risk population), the net benefit is assumed rather than mathematically modeled by the study team. For an average- or low-risk individual, typically assumed as ≤1 month of additional quality-adjusted life expectancy. Model documentation will provide further details, including definitions of high-risk factors and their individualized benefits (often, assumed as 1–2 months of additional quality-adjusted life expectancy)
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